Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on material properties and filtration efficiency, with no mention of AI or ML.

Therapeutic

No
A surgical face mask is primarily a barrier to prevent the transfer of microorganisms and particulate materials, not to treat or alleviate a medical condition.

Diagnostic

No

The device is a surgical face mask, which is a personal protective equipment (PPE) designed to protect against the transfer of microorganisms, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, multi-layer mask made of materials like polypropylene, urethane elastic fiber, and aluminum, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the mask is for protecting against the transfer of microorganisms, blood and body fluids, and particulate materials. This is a physical barrier function, not a diagnostic function performed in vitro (outside the body).
Device Description: The description details the physical construction of the mask and its materials. There is no mention of reagents, assays, or any components used to analyze samples from the human body.
Performance Studies and Key Metrics: The performance studies focus on the physical properties of the mask (filtration efficiency, fluid resistance, flammability, breathability) and biocompatibility. These are relevant to a barrier device, not a diagnostic test.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical face mask does not perform any of these functions.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

Product codes

FXX

Device Description

Surgical Face Mask is single use multi-layer mask with outer layer and inner layer (spun-bond polypropylene) that sandwich a meltblown polypropylene filter material. Earloops are of urethane elastic fiber and not made with natural rubber latex; The nose piece is a white aluminum strip covered by PP covering. All of the materials used in the construction of the surgical mask are being used in currently marketed devices.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

operating room personnel and other general healthcare workers

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The performance tests of Non Woven Face Mask were conducted.

A ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
A ASTM F1862 Standard test method for resistance of medical face masks to penetration by synthetic blood (Horizontal projection of fixed volume at a known velocity)
A ASTM F 2101-14 Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
MIL-M-36954C Military Specification - Mask, Surgical, Disposable
16 CFR Part 1610 STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES

Biocompatibility tests were performed:

ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization

Performance Testing (ASTM F2100-19) was conducted to test Fluid resistance, particle filtration efficiency, bacterial filtration efficiency, flammability class, Differential Pressure of Surgical Face Mask. Sample size was 3 non-consecutive lots, with each lot containing 32 samples for some tests. Results indicate the device meets Level 3 classification.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Key metrics reported are:

Fluid resistance: 3 non-consecutive lots, 1st lot: 30 of 32 samples >99.9% at 0.1μm pass at 160 mmHg; 2nd lot: 29 of 32 samples pass at 160mmHg; 3rd lot: 29 of 32 samples >99.9% at 0.1μm pass at 160mmHg.
Particle Filtration Efficiency: 3 non-consecutive lots, 1st lot: 32 samples >99.9% at 0.1 μm; 2nd lot: 32 samples >99.9% at 0.1μm; 3rd lot: 32 samples >99.9% at 0.1µm.
Bacterial Filtration Efficiency: 3 non-consecutive lots, 1st lot: 32 samples >99.9%; 2nd lot: 32 samples >99.9%; 3rd lot: 32 samples >99.9%.
Flammability Class: 3 non-consecutive lots, Each lot: 32 samples: Class 1.
Delta – P: 3 non-consecutive lots, 1st lot: 4.1 to 4.5 mmH2O/cm2; 2nd lot: 4.0 to 4.6 mmH2O/cm2; 3rd lot: 3.7 to 3.9 mmH2O/cm2.
Biocompatibility: Under the conditions of the study, the device was found non-cytotoxic", "non-irritating", or "non-sensitizing.

Predicate Device(s)

K173062

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

June 4, 2021

Juntech(Jiaxing)Healthcare Materials Co,.Ltd % Gamma Zhang RA Manager Feiying Drug&Medical Consulting Technical Service Group Rm 218, Building 2, Yike Intelligent Innovation Park, No. 232 Kezhu Road, Huangpu, Guangzhou Guangzhou, Guangdong 510000 China

Re: K203704

Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 28, 2021 Received: May 5, 2021

Dear Gamma Zhang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Ryan Ortega, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203704

Device Name Surgical Face Mask

Indications for Use (Describe)

Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510 (k) Summary

This 510(k) Summary is submitted in accordance with requirements of Title 21, CFR Section 807.92.

(1) Applicant information

510 (k) owner's name:	Juntech (Jiaxing) Healthcare Materials Co,.Ltd
Address:	No.4 Plant, No1 build of North of Yubei St, and Zhengdong Rd,
Yuxin Town Nanhu District, Jiaxing Zhejiang, China
Contact person:	Cam Sun
Phone number:	86-573-83178618
Fax number:	86-573-83178620
Email:	cam.sun@juntai-tech.com
Date of summary prepared:	2021-04-27

(2) Proprietary name of the device

Trade name:	Surgical Face Mask
Regulation name:	Surgical apparel
Regulation number:	21 CFR 878.4040
Product code:	FXX
Review panel:	General & Plastic Surgery
Regulation class:	Class II

(3) Predicate device

Sponsor	V&Q Manufacturing Corporation
Device Name	Face Mask, Surgical Mask, Surgical Face Mask
510(k) Number	K173062
Product Code	FXX
Regulation Number	21 CFR 878.4040
Regulation Class	II

(4) Description/ Design of device

Surgical Face Mask is single use multi-layer mask with outer layer and inner layer (spun-bond polypropylene) that sandwich a meltblown polypropylene filter material. Earloops are of urethane elastic fiber and not made with natural rubber latex; The nose piece is a white aluminum strip covered by PP covering. All of the materials used in the construction of the surgical mask are being used in currently marketed devices.

4

(5) Indications for use

Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

(6) Materials

| Component of | Material of | Body Contact Category
(ISO 10993-1) | Contact Duration (ISO
10993-1) |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|------------------------------------------|
| Device Requiring | Component | | |
| Biocompatibility | | | |
| Surgical Face Mask | Spunbond
polypropylene,
meltblown
polypropylene,
urethane elastic
fiber, Steel wire
covered by PP
covering. | Surface-contacting
device: skin | Prolonged contact: 24 hours
to 30 day |

The body-contacting material used in the Surgical Face Mask have all passed biocompatibility test. Details can be seen in "Biocompatibility Discussion".

(7) Technological Characteristics Comparison Table

Item	Subject device	Predicate device	Comparison
Trade name	Surgical Face Mask	Non Woven Face Mask	/
510 (k) number	K203704	K173062	/
Regulation number	21 CFR 878.4040	21 CFR 878.4040	Same
Regulation description	Surgical apparel	Surgical apparel	Same
Product code	FXX	FXX	Same
Class	II	II	Same
Indications for use/ Intended use	Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood	Non Woven Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against	Same

5

		and body fluids, and	transfer of
		particulate materials.	microorganisms,
blood and body fluids,
and
particulate materials.
	Inner
layer	Spun-bond
polypropylene	Spun-bond
polypropylene	Similar. All the materials of
Targeted device are used in
Predicate device.
	Middle
layer	Meltblown
polypropylene	Meltblown
polypropylene
Materials	Outer
layer	Spun-bond
polypropylene	Spun-bond
polypropylene
	Nosepiece	Steel wire covered by
PP covering	White aluminum strip
with PP covering
	Headband	Urethane elastic fiber	Urethane elastic fiber
or spun-bond
polypropylene
Mask style		Flat pleated	Flat pleated	Same
Design feature		Earloop	Earloop or tie-on	Same
Dimensions		17.5cm*9cm	175mm×95mm	Same
Latex		Not made with natural
rubber latex	Not made with natural
rubber latex	Same
Color		Blue (outer layer) and
white (inner layer)	Blue (outer layer) and
white (inner layer)	Same
Performance test result
Performance
Testing (ASTM
F2100-19)		Level 3	Level 2	Different. Note 1
Fluid resistance		3 non-consecutive lots,
1st lot: 30 of 32
samples >99.9% at 0.1µm
pass at 160 mmHg;
2nd lot: 29 of 32 samples
pass at 160mmHg;
3rd lot: 29 of 32
samples >99.9% at 0.1µm
pass at 160mmHg	Pass at 120 mmHg	Similar. Targeted device meets
ASTM F2100-19
Requirements for Level
3 Classification and ISO 22609:
≥29 of 32 test articles pass at
160 mmHg
Particle Filtration
Efficiency		3 non-consecutive lots,
1st lot: 32
samples >99.9% at
0.1 μm;	Average 99.74%
at 0.1 µm	Similar. Targeted device meets
ASTM F2100-19
Requirements for Level
3 Classification: ≥98% at 0.1µm

6

| | samples >99.9% at
0.1μm;
3rd lot: 32
samples >99.9% at 0.1µm | | |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Bacterial
Filtration
Efficiency | 3 non-consecutive lots,
1st lot: 32
samples >99.9%;
2nd lot: 32
samples >99.9%;
3rd lot: 32
samples >99.9% | 99.4% | Similar. Targeted device meets
ASTM F2100-19
Requirements for Level
3 Classification: ≥98% |
| Flammability
Class | 3 non-consecutive lots,
Each lot: 32 samples:
Class 1 | Class 1 | Similar. Targeted device meets
ASTM F2100-19
Requirements for Level
3 Classification: Class 1 |
| Delta – P | 3 non-consecutive lots,
1st lot: 4.1 to 4.5 mmH2O/cm2;
2nd lot: 4.0 to 4.6 mmH2O/cm2;
3rd lot: 3.7 to 3.9 mmH2O/cm2 | Average mmH2O/cm2 | 2.7 Similar. Targeted device meets
ASTM F2100-19
Requirements for Level
3 Classification: MIL-M-36954C Military Specification - Mask, Surgical, Disposable

16 CFR Part 1610 STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES >

During use, the Non Woven Face Mask will directly contact with user's skin, so we have it tested to demonstrate conformance to the following standards.

A ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization

| Test Methodology | Purpose | Acceptance
Criteria | Results | |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Testing
(ASTM
F2100-19) | To test the fluid
resistance, particle
filtration efficiency,
bacterial filtration
efficiency, flammability
class, Differential
Pressure of Surgical Face
Mask | Level 3 | Level 3 | |
| Fluid resistance | To evaluate surgical
facemasks and other types
of protective clothing
materials designed to
protect against fluid
penetration, as well as
simulate an arterial spray
and evaluate the
effectiveness of the test
article in protecting the
user from possible
exposure to blood and
other body fluids. | Per ASTM F1862
and ISO 22609, an
acceptable quality
limit of 4.0% is
met for a normal
single
sampling plan
when ≥29 of 32
test articles show
passing results. | 3 non-consecutive lots,
1st lot: 30 of 32 samples

99.9% at 0.1μm pass at
160 mmHg;
2nd lot: 29 of 32 samples
pass at 160mmHg;
3rd lot: 29 of 32 samples
99.9% at 0.1μm pass at
160mmHg | |
| Particle Filtration
Efficiency | To evaluate the non-viable
particle filtration
efficiency (PFE) of the
test article | ≥98% at 0.1μm | 3 non-consecutive lots,
1st lot: 32 samples
99.9% at 0.1μm;
2nd lot: 32 samples
99.9% at 0.1μm;
3rd lot: 32 samples
99.9% at 0.1μm | |
| Bacterial Filtration
Efficiency | To determine the filtration
efficiency of test articles
by comparing
the bacterial control
counts upstream of the
test article to the bacterial
counts downstream. | ≥98% | 3 non-consecutive lots,
1st lot: 32 samples
99.9% at 0.1μm;
2nd lot: 32 samples
99.9% at 0.1μm;
3rd lot: 32 samples
99.9% at 0.1μm | |
| Flammability Class | To evaluate the
flammability of plain
surface clothing textiles
by measuring the ease of
ignition and the speed of
flame spread. | Class 1 | 3 non-consecutive lots,
Each lot: 32 samples:
Class 1 | |
| Delta - P | To determine the |